[ Price : $8.95]
FDA and industry representatives report agreement on several issues in the 1/21 MDUFA 6 negotiating session.[ Price : $8.95]
FDA approves changes to the isotretinoin REMS to take effect in 180 days.[ Price : $8.95]
FDA issues a Warning Letter to Bio-Medical Pharmaceutical Manufacturing Corporation, citing widespread GMP violations at the compa...[ Price : $8.95]
FDA accepts for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type...[ Price : $8.95]
FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the co...[ Price : $8.95]
FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo...[ Price : $8.95]
Aurobindo Pharma says that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, T...[ Price : $8.95]
FDA tells Novo Nordisk that a new direct-to-consumer television ad for the newly launched Wegovy (semaglutide) oral weight-loss pi...